drugset / Trial / NCT03515018
Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chronic-phase chronic myelogenous leukemia (CML) aimed to avoid CML conversion (AP, BC). Hydroxyurea pulse therapy for chronic-phase CML patients is effective based on the investigator's previous studies, and the scheme cost lower than imatinib. It is not yet known the efficacy compared Hydroxyurea pulse therapy with imatinib for chronic-phase CML, especially to achieve hematological remission in short time. PURPOSE: Non-randomized trial to compare the effectiveness of hydroxyurea pulse therapy with that of imatinib in treating chronic-phase CML patients.
Timeline
- Start
- 2018-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-05-01
Publications
- Background Valent P, Herndlhofer S, Schneeweiss M, Boidol B, Ringler A, Kubicek S, Gleixner KV, Hoermann G, Hadzijusufovic E, Mullauer L, Sperr WR, Superti-Furga G, Mannhalter C. TKI rotation-induced persistent deep molecular response in multi-resistant blast crisis of Ph+ CML. Oncotarget. 2017 Apr 4;8(14):23061-23072. doi: 10.18632/oncotarget.15481.
- Background Huang J, Wang L, Chen L, Qun H, Yajing X, Fangping C, Xielan Z. Changing Treatment May Affect the Predictive Ability of European Treatment Outcome Study Scoring for the Prognosis of Patients with Chronic Myeloid Leukemia. Turk J Haematol. 2017 Mar 1;34(1):10-15. doi: 10.4274/tjh.2016.0156. Epub 2016 Oct 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | — | Oral |
| Comparator | Imatinib | Small molecule | 400 mg | Oral |